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Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE) | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)

A Randomized, Blinded, Placebo-Controlled, Phase 2a, Proof-of-Concept Study to Evaluate Efficacy, Safety, and Tolerability of GS-5718 in Participants With Cutaneous Lupus Erythematosus (CLE)

NCT05629208•Gilead Sciences

View on ClinicalTrials.gov

Summary

The goal of this clinical study is to test how edecesertib (formerly known as GS-5718) can be useful in treating Cutaneous Lupus Erythematosus (CLE) in participants with CLE. Information on what is happening in the body relating to CLE, how the body processes, is affected by and responds to the study drug, and any study drug side effects will also be collected in this study.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Either fulfill European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2019 classification criteria for systemic lupus erythematosus (SLE) and/or have biopsy confirmed Cutaneous Lupus Erythematosus (CLE) at any time.
•Must have active CLE at screening and Day 1. Individuals with acute CLE (ACLE) must have involvement of 2 distinct body areas.
•Cutaneous Lupus Erythematosus Disease Area and Severity Index activity - A (CLASI-A) score (excluding alopecia) of ≥ 8 and CLASI-A erythema score of ≥ 4 during screening and on Day 1. Individuals with SLE must have Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of ≥ 4 at screening.
•Presence of at least 1 representative lupus skin lesion amenable to punch biopsy and individual willingness to undergo skin punch biopsy at 2 time points.
•Must have documented prior intolerance or inadequate response at any time (per investigator judgement) to protocol-specified treatments.
•* Topical corticosteroids or topical calcineurin inhibitors.
•* Oral corticosteroids.
•* Any other nonbiologic standard-of-care therapy, including, but not limited to: chloroquine, quinacrine, hydroxychloroquine, azathioprine, mycophenolate mofetil (MMF), leflunomide, dapsone, or methotrexate (MTX).
•Individuals willing to comply with all study visits and assessments.

Exclusion Criteria

•Individuals with only chilblains lupus, lupus panniculitis, lupus tumidus and/or localized acute CLE involving only 1 distinct body area at screening and Day 1.
•Have highly active SLE (including but not limited to lupus nephritis, neuropsychiatric SLE, and/or vasculitis).
•Presence of active skin conditions other than cutaneous lupus that may interfere with assessing lupus-specific skin lesion(s) (eg, psoriasis, and/or drug-induced lupus).
•Meet protocol-specified infection or lab criteria.
•* Any active infection that is clinically significant (per investigator judgment).
•Any history of clinically significant liver disease.
•Significant cardiovascular disease.

Locations (17)

ARENSIA Exploratory Medicine, LLC

Phoenix, Arizona, United States

Center for Dermatology Clinical Research Inc.

Fremont, California, United States

University of Colorado, Barbara Davis Center, Center for Clinical Research

Aurora, Colorado, United States

Yale Center for Clinical Investigation (YCCI)

New Haven, Connecticut, United States

Clinical Research of West Florida, Inc.

Clearwater, Florida, United States

Reliant Medical Research

Miami, Florida, United States

HMD Research LLC

Orlando, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Dept. of Dermatology, Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine (PCAM)

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

April 17, 2023

Primary Completion Date

December 17, 2025

Completion Date

January 14, 2026

Last Updated

February 17, 2026

Enrollment

ACTUAL participants

Conditions

Cutaneous Lupus Erythematosus (CLE)

Interventions

Edecesertib

DRUG

Edecesertib Placebo

DRUG